Home » FDA Issues First-Ever Mandatory Recall for Kratom Products
FDA Issues First-Ever Mandatory Recall for Kratom Products
Drugs Regulatory Affairs
Soon after classifying kratom as an opioid, the FDA issued a mandatory recall for all of a Las Vegas company’s products made with the substance.
This is the first time the FDA issued a mandatory recall in response to a company ignoring a request for a voluntary recall. The agency said the current recall is only in response to concerns about a pathogen rather than a position on its legality.
FDA Commissioner Scott Gottlieb said the agency based its decision on risks posed by the products’ potential contamination with salmonella.